INTELLECTUAL PROPERTY RIGHTS

NATIONAL LEGISLATION - CANADA

Patent Act

PATENTED MEDICINES (continued)

88. (1) A patentee of an invention pertaining to a medicine shall, as required
by and in accordance with the regulations, or as the Board may, by order,
require, provide the Board with such information and documents as the
regulations or the order may specify respecting

(a) the identity of the licensees in Canada of the patentee;

(b) the revenue of the patentee, and details of the source of the revenue,
whether direct or indirect, from sales of medicine in Canada; and

(c) the expenditures made by the patentee in Canada on research and development
relating to medicine.

Additional information, etc.

(2) Where the Board believes on reasonable grounds that any person has
information or documents pertaining to the value of sales of medicine in Canada
by a patentee or the expenditures made by a patentee in Canada on research and
development relating to medicine, the Board may, by order, require the person to
provide the Board with any of the information or documents that are specified in
the order, or with copies thereof.

Compliance with order

(3) A person in respect of whom an order is made under subsection (1) or (2)
shall comply with the order within such time as is specified in the order or as
the Board may allow.

Information, etc., privileged

(4) Subject to section 89, any information or document provided to the Board
under subsection (1) or (2) is privileged, and no person who has obtained the
information or document pursuant to this Act shall, without the authorization of
the person who provided the information or document, knowingly disclose the
information or allow it to be disclosed, except for the purposes of the
administration of this Act.

1993, c. 2, s. 7.

Report

89. (1) The Board shall in each year submit to the Minister a report setting out

(a) the Board's estimate of the proportion, as a percentage, that the
expenditures of each patentee in Canada in the preceding year on research and
development relating to medicine is of the revenues of those patentees from
sales of medicine in Canada in that year; and

(b) the Board's estimate of the proportion, as a percentage, that the total of
the expenditures of patentees in Canada in the preceding year on research and
development relating to medicine is of the total of the revenues of those
patentees from sales of medicine in Canada in that year.

Basis of report

(2) The report shall be based on an analysis of information and documents
provided to the Board under subsections 88(1) and (2) and of such other
information and documents relating to the revenues and expenditures referred to
in subsection 88(1) as the Board considers relevant but, subject to subsection
(3), shall not be set out in a manner that would make it possible to identify a
person who provided any information or document under subsection 88(1) or (2).

Exception

(3) The Board shall, in the report, identify the patentees in respect of whom an
estimate referred to in subsection (1) is given in the report, and may, in the
report, identify any person who has failed to comply with subsection 88(1) or
(2) at any time in the year in respect of which the report is made.

Tabling of report

(4) The Minister shall cause a copy of the report to be laid before each House
of Parliament on any of the first thirty days on which that House is sitting
after the report is submitted to the Minister.

1993, c. 2, s. 7.

Inquiries

Inquiries

90. The Board shall inquire into any matter that the Minister refers to the
Board for inquiry and shall report to the Minister at the time and in accordance
with the terms of reference established by the Minister.

1993, c. 2, s. 7.

Patented Medicine Prices Review Board

Establishment

91. (1) The Patented Medicine Prices Review Board is hereby continued, and shall
consist of not more than five members to be appointed by the Governor in
Council.

Tenure

(2) Each member of the Board shall hold office during good behaviour for a
period of five years, but may be removed at any time by the Governor in Council
for cause.

Reappointment

(3) A member of the Board, on the expiration of a first term of office, is
eligible to be reappointed for one further term.

Acting after expiration of appointment

(4) A person may continue to act as a member of the Board after the expiration
of the person's term of appointment in respect of any matter in which the person
became engaged during the term of appointment.

Remuneration and expenses

(5) The members of the Board shall be paid such remuneration as may be fixed by
the Governor in Council and are entitled to be paid reasonable travel and living
expenses incurred by them in the course of their duties under this Act while
absent from their ordinary place of residence.

1993, c. 2, s. 7.

Advisory panel

92. (1) The Minister may establish an advisory panel to advise the Minister on
the appointment of persons to the Board, which panel shall include
representatives of the provincial ministers of the Crown responsible for health,
representatives of consumer groups, representatives of the pharmaceutical
industry and such other persons as the Minister considers appropriate to
appoint.

Consultation

(2) The Minister shall consult with an advisory panel established under
subsection (1) for the purpose of making a recommendation to the Governor in
Council with respect to the appointment of a person to the Board.

1993, c. 2, s. 7.

Chairperson and Vice-chairperson

93. (1) The Governor in Council shall designate one of the members of the Board
to be Chairperson of the Board and one of the members to be Vice-chairperson of
the Board.

Duties of Chairperson

(2) The Chairperson is the chief executive officer of the Board and has
supervision over and direction of the work of the Board, including

(a) the apportionment of the work among the members thereof and the assignment
of members to deal with matters before the Board and to sit at hearings of the
Board and to preside at hearings or other proceedings; and

(b) generally, the conduct of the work of the Board, the management of its
internal affairs and the duties of its staff.

Duties of Vice-chairperson

(3) If the Chairperson is absent or incapacitated or if the office of
Chairperson is vacant, the Vice-chairperson has all the powers and functions of
the Chairperson during the absence, incapacity or vacancy.

1993, c. 2, s. 7.

Staff

94. (1) Such officers and employees as are necessary for the proper conduct of
the work of the Board shall be appointed in accordance with the Public Service
Employment Act.

Idem

(2) Persons appointed under subsection (1) shall be deemed to be employed in the
Public Service for the purposes of the Public Service Superannuation Act.

Technical assistance

(3) The Board may engage on a temporary basis the services of persons having
technical or specialized knowledge to advise and assist in the performance of
its duties and, with the approval of the Treasury Board, the Board may fix and
pay the remuneration and expenses of those persons.

1993, c. 2, s. 7.

Principal office

95. (1) The principal office of the Board shall be in the National Capital
Region described in the schedule to the National Capital Act.

Meetings

(2) The Board may meet at such times and places in Canada as the Chairperson
deems advisable.

1993, c. 2, s. 7.

General powers, etc.

96. (1) The Board has, with respect to the attendance, swearing and examination
of witnesses, the production and inspection of documents, the enforcement of its
orders and other matters necessary or proper for the due exercise of its
jurisdiction, all such powers, rights and privileges as are vested in a superior
court.

Rules

(2) The Board may, with the approval of the Governor in Council, make general
rules

(a) specifying the number of members of the Board that constitutes a quorum in
respect of any matter; and

(b) for regulating the practice and procedure of the Board.

By-laws

(3) The Board may make by-laws for carrying out the work of the Board, the
management of its internal affairs and the duties of its staff.

Guidelines

(4) Subject to subsection (5), the Board may issue guidelines with respect to
any matter within its jurisdiction but such guidelines are not binding on the
Board or any patentee.

Consultation

(5) Before the Board issues any guidelines, it shall consult with the Minister,
the provincial ministers of the Crown responsible for health and such
representatives of consumer groups and representatives of the pharmaceutical
industry as the Minister may designate for the purpose.

Non-application of Statutory Instruments Act

(6) The Statutory Instruments Act does not apply to guidelines issued under
subsection (4).

1993, c. 2, s. 7.

Proceedings

97. (1) All proceedings before the Board shall be dealt with as informally and
expeditiously as the circumstances and considerations of fairness permit.

Differences of opinion among members

(2) In any proceedings before the Board,

(a) in the event of a difference of opinion among the members determining any
question, the opinion of the majority shall prevail; and

(b) in the event of an equally divided opinion among the members determining any
question, the presiding member may determine the question.

1993, c. 2, s. 7.

Orders

98. (1) The Board may, in any order, direct

(a) that the order or any portion thereof shall come into force at a future
time, on the happening of a contingency, event or condition specified in the
order or on the performance to the satisfaction of the Board, or a person named
by it, of any terms specified in the order; and

(b) that the whole or any portion of the order shall have effect for a limited
time or until the happening of a specified event.

Interim orders, etc.

(2) The Board may make interim orders or reserve further directions for an
adjourned hearing of a matter.

Rescission and variation

(3) The Board may vary or rescind any order made by it and may re-hear any
matter.

Certificates

(4) Where any person satisfies the Board that the Board would not have
sufficient grounds to make an order under section 83 in respect of the person,
the Board may, after the person pays any fees required to be paid by the
regulations, issue to the person a certificate to that effect, but no
certificate is binding on the Board.

1993, c. 2, s. 7.

Enforcement of orders

99. (1) Any order of the Board may be made an order of the Federal Court or any
superior court of a province and is enforceable in the same manner as an order
of the court.

Procedure

(2) To make an order of the Board an order of a court, the usual practice and
procedure of the court in such matters may be followed or, in lieu thereof, the
Board may file with the registrar of the court a certified copy of the Board's
order, and thereupon the order becomes an order of the court.

Effect of variation or rescission

(3) Where an order of the Board that has been made an order of a court is varied
or rescinded by a subsequent order of the Board, the subsequent order of the
Board shall be made an order of the court in the manner described in subsection
(1), and the order of the court shall be deemed to have been varied or rescinded
accordingly.

Option to enforce

(4) Nothing in this section prevents the Board from exercising any of its powers
under this Act.

1993, c. 2, s. 7.

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